by Inga Rose, Founder and CEO, Reference Medicine
Cancer research is built around timelines. A team may know when it wants to complete validation, submit to a regulator, or launch a new diagnostic. Yet one of the inputs that can determine whether those milestones remain achievable is considerably less predictable: access to the right biospecimens.
Researchers are well aware of this challenge, which is why specimen sourcing is often one of the first things an R&D team considers when planning a new project. But planning early does not eliminate every bottleneck. An experiment may reveal that a collection method doesn’t work for a novel target. A regulator may decide that a validation cohort of 50 samples needs to become 500, or request evidence from an additional cancer type. A specimen that appeared suitable on paper may fail quality control or prove insufficiently characterized once it reaches the laboratory.
When that happens, a project can quickly move from "on schedule" to "blocked."
The lesson is not simply that researchers need faster access to biospecimens. It’s that we need to rethink what speed in biospecimen procurement actually means. The fastest specimen to arrive is not necessarily the specimen that gets research moving the fastest. Accelerating cancer innovation requires building procurement strategies that anticipate uncertainty, prioritizing usable specimens over impressive inventory numbers, and reducing the risk of discovering problems after the clock is already ticking.
Plan for the specimen you need, and the specimen you might need next
Cancer diagnostics are becoming more sophisticated, and the specimens required to develop and validate them are becoming more specialized along with them. An FFPE tissue block from a common cancer may be relatively straightforward to source. But cerebrospinal fluid, matched blood and tumor specimens, fresh material, or samples containing an uncommon biomarker can be an entirely different proposition.
Researchers cannot anticipate every request a regulator will make or every unexpected result that will emerge during development. They can, however, build some flexibility into procurement planning.
That begins with asking more than "Where can we find the samples in our protocol?". Teams should also consider which requirements are scientifically essential, what additional samples might become necessary during validation, and which specimen types will become difficult to source quickly if a new question emerges.
This is particularly important for young companies developing novel technologies. Ambitious science sometimes comes with specimen requirements that are disconnected from how oncology care actually works. If a diagnostic ultimately requires a specimen to be collected in a way that is extraordinarily difficult for a hospital, physician, or nurse to accommodate, that’s not merely a procurement challenge during development; it may eventually become a commercialization challenge.
A useful feasibility question, therefore, is surprisingly simple: How would this specimen be collected from a patient in the real world?
If the answer requires unusual procedures, extremely tight processing windows, or workflows that do not fit naturally into standard care, researchers should examine those constraints early. Difficulty sourcing specimens can sometimes be an early warning about difficulty implementing the technology itself.
Don't confuse a large biobank with immediate access
When a project is under time pressure, an enormous existing inventory can sound reassuring. If a provider has access to tens of thousands of cancer specimens, surely the samples a researcher needs must be somewhere in there. Not necessarily.
The meaningful question is not how many specimens exist in a database. It’s how many meet the requirements of the research being conducted today.
Older collections may have been processed under different protocols, accompanied by limited clinical information, or collected before current standards of care emerged. A database containing 100,000 cancer specimens becomes far less impressive if the vast majority are a decade old and a project requires samples collected within the past three years.
This is why a well-run biobank should not be judged by how full its freezers are. An inventory strategy should evolve with the science, adding specimens and collection modalities as demand emerges while continually reassessing whether what has been banked remains relevant.
For researchers, this also means knowing when to stop searching existing inventory. If the available specimens are too old, poorly characterized, or simply do not match the scientific requirements, continuing to search more databases may not be the fastest strategy. Prospective collection can be the more efficient path.
In some cases, the best approach may be both: use an existing cohort, with appropriate recognition of its limitations, to begin generating data, while a prospective collection builds the more precisely matched cohort needed for later stages of the program.
For rare specimens, smarter screening can matter more than a bigger search
The challenge becomes even greater when research depends on rare cancers or uncommon biomarkers. Some molecular alterations of significant interest in oncology occur in only a tiny fraction of patients. Finding enough positive specimens by sequencing every available case can be prohibitively expensive, while simply searching larger inventories may not solve the problem.
A more strategic approach is to triage.
For biomarkers that can first be assessed using a less costly screening method, specimens can be narrowed to a smaller pool before more expensive molecular testing is performed. This can make it feasible to identify extremely rare cases without applying the most expensive testing methodology to every specimen in a collection.
The broader principle applies beyond any particular biomarker: the procurement strategy should reflect the biology of what researchers are trying to find. Rare does not always mean impossible, but finding rare specimens efficiently requires more than casting an increasingly wide net. It requires understanding which patients are most likely to harbor the characteristic of interest and using the available scientific information to narrow the search intelligently.
Measure time to a usable specimen, not time to delivery
There’s an old project-management maxim: you can have something good, fast, or cheap, but you can only choose two. Biospecimen procurement has its own version of that tension.
Speed matters, particularly when a regulatory response, validation milestone, or product launch is at stake. But a sample that arrives tomorrow and fails in the laboratory has not saved a researcher time.
Neither price nor turnaround time is a reliable proxy for quality. An expensive prospective collection can still produce unusable specimens. A low-cost specimen available for immediate shipment may turn out to have inadequate material, questionable characterization or processing that makes it unsuitable for the intended assay.
Researchers therefore need to measure speed differently. The goal is not the shortest possible time to specimen. It is the shortest reliable time to a usable specimen.
That means quality cannot be something researchers discover only after delivery. Before purchasing, they should ask what a provider actually knows about the material being offered. Are the specimens physically in the provider's laboratory, or is the company representing inventory held somewhere else? Has a pathology team reviewed the tissue? Has the provider performed relevant quality assessments? Has DNA or RNA been extracted recently, if that matters to the intended application? How were the samples collected and processed?
A useful rule is to ask the provider the same questions your own scientists will ask when the specimens arrive. If you will need to verify a particular attribute before trusting the material in your research, find out whether someone has already performed that verification.
Transparency is a speed strategy
This level of diligence becomes especially important in a biospecimen marketplace where researchers may not always know who physically possesses the material they are being offered.
Brokerage itself is not necessarily visible to the end user. A company may present a specimen in a spreadsheet without having collected it, stored it, examined it, or performed quality assessment on it. Researchers can consequently spend time evaluating what appear to be multiple sourcing options without realizing that several vendors may lead back to the same underlying institution or even the same patient.
That opacity creates more than a procurement inconvenience. It can complicate cohort diversity, increase costs, and leave researchers unable to independently evaluate specimen quality until the material arrives.
At minimum, researchers should know what role each organization plays in the chain. If a supplier is brokering material rather than providing specimens it has collected and evaluated itself, that should be transparent. Researchers can then make an informed decision about what additional verification is necessary. Transparency, in other words, should not be viewed as paperwork that slows procurement down.
Build procurement for uncertainty
Cancer research will always contain unknowns. That’s the nature of developing something that has never existed before. Researchers will discover that an assay behaves differently than expected. Regulators will ask questions no one anticipated. Technologies will evolve, and today's ideal specimen may not be tomorrow's.
The biospecimen strategy surrounding that research should therefore be designed not only for the samples a team knows it needs today, but for its ability to respond when circumstances change.
The goal should not be to move a box from a freezer to a laboratory as quickly as possible. It should be to remove as much uncertainty as possible between the moment a researcher identifies a need and the moment a high-quality, appropriate specimen can begin generating useful data. This gives researchers more time to do what the specimens were collected for in the first place: move cancer innovation forward.
About the author
Inga Rose is the Founder of Reference Medicine, and has spent her career serving the healthcare industry, primarily focused on oncology clinical research and diagnostics. Reference Medicine offers a comprehensive product line of specimens tailor-made for oncology test developers - giving patients meaning to their disease and helping biotech teams spend less time sourcing and more time building the next life-saving diagnostic.
At Caris Life Sciences from 2008 to 2019, Inga’s experience ranged from project manager to VP of Lab Operations, and subsequently joined Science Care’s executive team, the leading body donation program globally. In these roles, she experienced first-hand the need for good specimens to build and maintain high-quality diagnostics.